N/A
N=65
Comparison of 2 Laryngoscopes for Endotracheal Intubation in Children Younger Than 2 Years Old
Endotracheal Intubation
Bottom Line
View on ClinicalTrials.gov: NCT01488370 ↗Enrolled (actual)
65
Serious AEs
0.0%
Results posted
May 2017
Primary outcome: Primary: Measurement of Time to Intubation Will Begin at the Time of Mouth Opening and End With the Removal of the Tip of the Laryngoscope Blade From the Patient's Mouth After Successful Endotracheal Intubation. — 30.8; 42.1; 21.5 Seconds
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Endotracheal intubation (Device)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Loma Linda University
- Primary completion
- Jul 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Measurement of Time to Intubation Will Begin at the Time of Mouth Opening and End With the Removal of the Tip of the Laryngoscope Blade From the Patient's Mouth After Successful Endotracheal Intubation. |
30.8; 42.1; 21.5 | — |
| SECONDARY Successful Intubation After One Laryngoscopy Attempt |
17; 16; 16 | — |
| SECONDARY Successful Intubation After Two Laryngoscopy Attempts |
3; 5; 2 | — |
| SECONDARY Successful Intubation After Three Laryngoscopy Attempts |
1; 1; 1 | — |
| SECONDARY Successful Intubation After Four Laryngoscopy Attempts |
1; 0; 0 | — |
Summary
This is a prospective randomized clinical study to be performed in pediatric patients under the age of 2 years who are undergoing surgical procedures requiring endotracheal intubation. Time to endotracheal intubation will be compared between patients intubated using a GlideScope® video laryngoscope, those intubated with a Storz DCI® video laryngoscope, and those intubated by standard direct laryngoscopy. The study hypothesis is that the time to endotracheal intubation will be decreased in the Storz DCI® video laryngoscope group when compared to the GlideScope® video laryngoscope group and standard laryngoscopy.
Eligibility Criteria
Inclusion Criteria
- Pediatric patients under the age of 2 years undergoing surgeries requiring endotracheal intubation at LLUMC will be eligible for participation in this study
Exclusion Criteria
- Children with increased pulmonary aspiration risk;
- Prior documentation of difficult endotracheal intubation;
- Those that lack legal representative consent
Data sourced from ClinicalTrials.gov (NCT01488370). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.